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Organization name
UDI-DI code
Reference / catalog number

PolyQ Stain 1 step detection… — IVDR Class A IVDR

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Sep 20, 2023

PolyQ Stain 1 step detection system goat anti-mouse HRP

42555978DETECTIONPP

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: biocyc Biotechnologie GmbH & Co. KG
UDI-DI code: 04255597801660
Reference / catalog number: DS-121-005

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Manufacturer information

Organization name: biocyc Biotechnologie GmbH & Co. KG
SRN: DE-MF-000031533
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: PolyQ Stain 1 step detection system goat anti-mouse HRP
UDI-DI code: 04255597801660
Basic UDI-DI: 42555978DETECTIONPP
Reference / catalog number: DS-121-005
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Detection system intended for immunohistochemical (IHC) applications used for the qualitative detection of antigens in formalin-fixed, paraffin-embedded (FFPE) tissue sections and cryostat tissues based on the specific antigen-antibody reaction.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030711IMMUNOHISTOLOGY KITS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

Certificates

Certificate health across this manufacturer's portfolio.

HX 1108389-1Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 0197Expiry: Jun 20, 2029